The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Invisio Irl Digital Rigid Laparoscope System.
| Device ID | K042069 |
| 510k Number | K042069 |
| Device Name: | INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence E Sullivan |
| Correspondent | Terrence E Sullivan ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-11-01 |
| Summary: | summary |